Fenoglide (Page 6 of 7)

14.2 Severe Hypertriglyceridemia

The effects of fenofibrate on serum triglycerides were studied in two randomized, double-blind, placebo-controlled clinical trials of 147 hypertriglyceridemic patients. Patients were treated for eight weeks under protocols that differed only in that one entered patients with baseline TG levels of 500 to 1500 mg/dL, and the other TG levels of 350 to 500 mg/dL. In patients with hypertriglyceridemia and normal cholesterolemia with or without hyperchylomicronemia, treatment with fenofibrate at dosages equivalent to 120 mg FENOGLIDE (fenofibrate) Tablets per day decreased primarily very low density lipoprotein (VLDL) triglycerides and VLDL cholesterol. Treatment of patients with elevated triglycerides often results in an increase of LDL-C (see Table 5).

Table 5. Effects of Fenofibrate in Patients With Severe Hypertriglyceridemia
*
p=<0.05 vs. placebo

Study 1

Placebo

Fenofibrate

Baseline TG levels350 to 499 mg/dL

N

Baseline(Mean)

Endpoint(Mean)

%Change(Mean)

N

Baseline(Mean)

Endpoint(Mean)

%Change(Mean)

Triglycerides

28

449

450

-0.5

27

432

223

-46.2*

VLDL Triglycerides

19

367

350

2.7

19

350

178

-44.1*

Total Cholesterol

28

255

261

2.8

27

252

227

-9.1*

HDL Cholesterol

28

35

36

4

27

34

40

19.6*

LDL Cholesterol

28

120

129

12

27

128

137

14.5

VLDL Cholesterol

27

99

99

5.8

27

92

46

-44.7*

Study 2

Placebo

Fenofibrate

Baseline TG levels500 to 1500 mg/dL

N

Baseline(Mean)

Endpoint(Mean)

%Change(Mean)

N

Baseline(Mean)

Endpoint(Mean)

%Change(Mean)

Triglycerides

44

710

750

7.2

48

726

308

-54.5*

VLDL Triglycerides

29

537

571

18.7

33

543

205

-50.6*

Total Cholesterol

44

272

271

0.4

48

261

223

-13.8*

HDL Cholesterol

44

27

28

5.0

48

30

36

22.9*

LDL Cholesterol

42

100

90

-4.2

45

103

131

45.0*

VLDL Cholesterol

42

137

142

11.0

45

126

54

-49.4*

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